FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756806539
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
103P10
Catalog number
103P10
Device description
ELBOW IMMOBILIZER
Published
2021-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756806539PackageGS112In Commercial Distribution
00749756806534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975680653950749756806539
00749756806534007497568065347497568065340749756806534

GMDN Terms#

Term, Definition table
TermDefinition
Arm immobilizerA non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426263943Medline-MicrotekMicrotek Medical LLCFMQ2026-01-21
20884389198749MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-11-14
10190676008299PoseyPOSEY PRODUCTS, LLCFMQ2025-07-16
00749756399173DeRoyalDEROYAL INDUSTRIES, INC.FMQ2025-06-19
10810178883117ViveVIVE HEALTH LLCFMQ2025-05-19
10815614021115Elevate ArmBoard Extender HSemler Technologies, Inc.FMQ2025-05-19
10815614021122Elevate ArmBoard Extender H Semler Technologies, Inc.FMQ2025-05-19
00748426141128Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
06974737270125EMSSSHANGHAI EMSS MED&TECH CO.,LTD.FMQ2025-03-12
10815614021092mBrace 4285 Wrist Support with HookSemler Technologies, Inc.FMQ2025-02-27
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
10888277673472MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-01-04
10197344112937MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112944MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112258MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-14
10888277699557MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-08-07
09010279001050iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001289iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001702iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001719iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10810113577484ViveVIVE HEALTH LLCFMQ2024-07-17
00749756394567DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394574DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394581DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394598DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394604DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394611DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
06931918129979HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
06931918189829HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
50080196281372MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01